Ethicon recalls PDS II sutures with specific product numbers due to weak tensile strength. Affected items may not hold properly during surgery, risking complications.
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Ethicon is recalling certain PDS II (polydioxanone) sutures that failed internal tensile strength tests. These sutures could become too weak during surgery, potentially causing complications if used in procedures requiring strong stitching.
The recalled sutures did not meet tensile strength requirements in internal testing. This means they might not hold properly during surgery, potentially leading to complications like premature breakage in critical areas.
Surgical professionals and patients who received the recalled sutures during procedures. The risk is low for most users as the issue is limited to specific product batches.
Check the product numbers listed in the recall notice (e.g., Z844G-50, D10065-05) or the UDI-DI codes provided. The lot numbers also appear in the recall list.
Look for the specific product numbers listed in the recall notice (e.g., Z844G-50, D10065-05) on the suture packaging.
If you have the recalled suture, contact Ethicon directly for further guidance on disposal or replacement.
No. Only specific product numbers and lot numbers listed in the recall notice are affected.
Check the product numbers or UDI-DI codes on the suture packaging against the list provided in the recall notice.
The recall does not require immediate discontinuation; however, if you have the recalled product, contact Ethicon for guidance.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2617-2023 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2617-2023 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
